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Docetaxel in Treating Patients With Advanced Cancer of the Cervix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003445
Recruitment Status : Completed
First Posted : April 23, 2004
Last Update Posted : June 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with advanced cancer of the cervix.


Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: docetaxel Phase 2

Detailed Description:

OBJECTIVES: I. Assess the antitumor activity of docetaxel as neoadjuvant chemotherapy in patients with locally advanced squamous cell carcinoma of the cervix. II. Assess the tumor response, toxic effect, and survival rate of this regimen in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Treatment is repeated every 3 weeks for 3 courses. Patients are followed every 3 months posttreatment.

PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma
Study Start Date : December 1997
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven stage IIB, IIIA, IIIB, and IVA squamous cell carcinoma of the cervix Bidimensionally measurable disease No bilateral hydronefrosis

PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL Leukocytes at least 4,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) AST less than 1.25 times ULN Renal: BUN less than 30 mg/dL AND Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No prior or other concurrent malignancies, other than properly treated basal cell skin cancer

PRIOR CONCURRENT THERAPY: Not specified

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003445


Locations
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Argentina
Unidad Oncologica Del Comahue
Neuquen, Argentina, 8300
Sponsors and Collaborators
Grupo Oncologico Cooperativo del Sur
Investigators
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Study Chair: Carlos Teodoro Vallejo, MD Grupo Oncologico Cooperativo del Sur
More Information
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ClinicalTrials.gov Identifier: NCT00003445    
Other Study ID Numbers: GOCS-04-CC-97
CDR0000066473 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-V98-1456
First Posted: April 23, 2004    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: September 2001
Keywords provided by National Cancer Institute (NCI):
stage III cervical cancer
stage IIB cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
 Genital Diseases, Female
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action